System for securing sutures

ABSTRACT

Described herein are systems and methods for securing sutures that obviate the need for tying knots. Instead of tying two ends of a suture or two sutures together with a knot, two or more suture portions can be fused or cauterized together using heat. A device can be applied to adjacent suture portions that heats the suture portions and causes the suture portions to fuse together, effectively securing the suture portions together without a knot.

CROSS REFERENCE TO RELATED APPLICATION

The application claims the benefit of U.S. Provisional PatentApplication No. 61/740,769 filed on Dec. 21, 2012, which is hereinincorporated by reference.

FIELD

This disclosure is related to devices and methods for securing surgicalsutures.

BACKGROUND

Surgically placed sutures are frequently used in many different surgicalprocedures. Exemplary procedures include closing an open section ofblood vessel to secure placement of tubes for cardiopulmonary bypass andimplantation of a prosthetic device within the heart. In suchprocedures, different suture types and suture patterns are often used,such as purse string sutures, mattress sutures, running sutures, andothers. Conventionally, at the end of such a procedure, the two freeends of each suture are tied together in a knot to secure the suture inplace.

SUMMARY

Described herein are systems and methods for securing sutures thatobviate the need for tying knots. Instead of tying two ends of a sutureor two suture portions together with a knot, two or more suture portionscan be fused or cauterized together using heat. A device can be appliedto adjacent suture portions that heats the suture portions and causesthe suture portions to fuse together, effectively securing the sutureportions together.

Some embodiments of a suture securement device comprise a handle, anelongated outer shaft having a proximal end portion coupled to thehandle and a distal end portion opposite the proximal end, an innershaft movable proximally and distally within the outer shaft, anelectrical heating element positioned within the outer shaft, and asuture holder at the distal end portion of the outer shaft. The sutureholder can has an open position and a closed position, wherein in theopen position the suture holder is configured to receive sutures, and inthe closed position the suture holder is configured to hold sutures andprevent longitudinal movement of held sutures relative to the outershaft. Actuation of the device causes the inner shaft and the heatingelement to move distally relative to the outer shaft and the sutureholder, such that the distal end portion of the inner shaft causes thesuture holder to move from the open position to the closed position, andsuch that the heating element moves into the proximity of the sutureholder to fuse together sutures held by the suture holder.

In some embodiments, the suture holder comprises a first portion and asecond portion that are hingedly coupled together for articulationbetween the open position and the closed position, such as in aclamshell-type configuration. The first and second portions of thesuture holder can be coupled by an elastically flexible hinge thatbiases the first and second portions toward the open position, such thatthe suture holder releases the fused sutures when the inner shaft movesproximally off of the suture holder. The first portion of the sutureholder can be fixed relative to the outer shaft and a second portion ofthe suture holder can move between the open position and the closedposition. In other embodiments, both portions of the suture holder canmove. In some embodiments, the suture holder has a sloped proximalsurface and the inner shaft has a sloped distal surface, and contactbetween the sloped proximal surface and the sloped distal surface causesthe suture holder to close. In some embodiments, the suture holdercomprises a proximal recess and the heating element moves at leastpartially into the proximal recess, such as to both fuse the sutures andto cut off free ends of the sutures.

In some embodiments, the device can comprise an electrical power sourcein the handle that is electrically coupled to the heating element. Inother embodiments, the device can be electrically coupled to anelectrical power source.

In some embodiments, the outer shaft comprises a longitudinal slot atthe distal end portion of the outer shaft and, in the open position,free ends of sutures received by the suture holder extend out of thedevice through the slot to allow manual tensioning of the sutures. Insome embodiments, the inner shaft comprises a longitudinal slot at thedistal end portion of the inner shaft and, in the closed position, freeends of sutures held by the suture holder extend out of the devicethrough the slots in the inner and outer shafts.

In some embodiments, the heating element is positioned within the innershaft and the inner shaft comprises at least two radial openingsadjacent to the heating element to vent heat from the heating element.

In some embodiments, the device includes a suture collar at the distalend of the outer shaft. The suture collar can comprise a central openingfor collaring sutures received by the suture holder, and a lateral gatethat allows sutures to enter laterally into the central opening in aradially inward direction through the lateral gate, and the lateral gateblocks sutures from exiting the central opening in a radially outwarddirection. A stationary part of the suture holder can be fixed to aproximal side of a suture collar. The outer shaft can include a slotextending proximally from a distal end of the outer shaft, and the slotcan be circumferentially aligned with the lateral gate in the suturecollar and a lateral opening in the suture holder such that anintermediate portion of a suture can be laterally inserted through theslot and through the lateral gate and into the central opening and intothe suture holder.

Some embodiments of a suture securement device comprise a handle, anelongated outer shaft having a proximal end portion coupled to thehandle and a distal end portion opposite the proximal end, an electricalheating element positioned within the outer shaft, and a suture collarat the distal end portion of the outer shaft. The suture collar has acentral opening for collaring sutures and a lateral gate that allows anintermediate portion of a suture to enter laterally into the centralopening in a radially inward direction through the lateral gate, and thegate blocks sutures from exiting the central opening in a radiallyoutward direction. Actuation of the device causes the heating element tofuse together sutures collared by the suture collar.

In some embodiments, the suture collar is generally disk-shaped andfurther comprises a generally wedge-shaped slot extending radially froma radially outer perimeter of the suture collar to the lateral gate. Insome embodiments, the lateral gate comprises an elastically flexibleflap that deflects to allow sutures to pass into the central opening,such that a radially inward force from a suture causes the flap toelastically deflect into the central opening to open the lateral gate.

In some embodiments, the device further comprises an air conduitextending from the handle to the distal end portion of the outer shaftand configured to conduct air to the distal end portion to help cool theheating element and/or the fused sutures. The air conduit can be coupledto a pump in the handle or to an external air supply source.

The foregoing and other objects, features, and advantages of thisdisclosure will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view of an exemplary suture securement device disclosedherein.

FIG. 2 is a top view of another exemplary suture securement devicedisclosed herein.

FIG. 3 is a top view of yet another exemplary suture securement devicedisclosed herein.

FIG. 4 shows two sutures fused together.

FIG. 5 shows two sutures secured together with an exemplary clipdisclosed herein.

FIG. 6 is a side view of still another exemplary suture securementdevice disclosed herein.

FIG. 7 is a cross-sectional side view of a distal end of the device ofFIG. 6.

FIG. 8 is a cross-sectional top view of a distal end of the device ofFIG. 6.

FIG. 8A is a cross-section end view of the distal end of the device ofFIG. 6.

FIG. 9 is a side view of another exemplary suture securement devicedisclosed herein.

FIG. 10 is a cross-sectional side view of a distal end of the device ofFIG. 10.

FIG. 11 is a cross-sectional top view of a distal end of the device ofFIG. 10.

FIG. 11A is a cross-section end view of the distal end of the device ofFIG. 10.

FIG. 12 is a perspective view of another exemplary suture securementdevice disclosed herein.

FIG. 13 is a side view of the device of FIG. 12.

FIG. 14 is cross-sectional side view of a handle portion of the deviceof FIG. 12.

FIG. 15 is a perspective view of a distal portion of the device of FIG.12 in an open position, with an outer shaft of the device partially cutaway.

FIG. 16 is a top view of the distal portion of the device of FIG. 12 inthe open position, with the outer shaft not shown.

FIG. 17 is a perspective view of the distal portion of the device ofFIG. 12 in the open position, with the outer shaft and inner shaft notshown.

FIG. 18 is another perspective view of the distal portion of the deviceof FIG. 12 in the open position, with the outer shaft and inner shaftnot shown.

FIG. 19 is a perspective view of a distal portion of the device of FIG.12 in closed position, with an outer shaft of the device partially cutaway.

FIG. 20 is a cross-sectional top view of the distal portion of thedevice of FIG. 12 in a closed position, with the outer shaft not shown.

FIG. 21 is a perspective view of the distal portion of the device ofFIG. 12 in the closed position, with the outer shaft and inner shaft notshown.

FIG. 22 is a perspective view from a proximal end of a suture holder anda suture collar of the device of FIG. 12 in the closed position, withother portions of the device not shown.

FIG. 23-25 are side, proximal end, and distal end views, respectively,of an exemplary suture holder of the device of FIG. 12.

FIG. 26 is distal end view of an exemplary suture collar of the deviceof FIG. 12.

FIG. 27 is a perspective view of the distal portion of the device ofFIG. 12 in the open position, with the outer shaft and inner shaft notshown, and further comprising an exemplary fusing sleeve positionedaround the sutures.

DETAILED DESCRIPTION

Described herein are systems and methods for securing sutures thatobviate the need for tying knots. Instead of tying two ends of a sutureor two or more sutures together with a knot, the suture portions can befused or cauterized together using heat. A device can be applied to twoor more adjacent suture portions that heats the suture portions andcauses the suture portions to fuse together, effectively securing thesuture portions together.

While this disclosure primarily describes securing two suture portionstogether, embodiments of the disclosed systems and methods can also beused to secure three or more suture portions together in a similarmatter. The two suture portions being secured together can be twoportions of the same suture (e.g., opposite ends) or portions of twodifferent sutures. Furthermore, the suture portions secured together canbe any portion along a length of a suture, such as an end of the sutureor a portion of the suture between its ends.

The disclosed systems and methods can be used with any type of suturesthat are capable of being fused or cauterized together when heat isapplied. Exemplary suture materials can comprise biological tissues(e.g., collagen-based tissue), polyglycolide, polydioxanone, polyester,nylon, polypropylene, and other polymeric materials. Some suturescomprise several strands of fibers braided or woven together.

FIG. 1 shows a portion of an exemplary device 10 that is configured tofuse sutures together using heat. The device 10 comprises a handleportion 12 that a user holds to operate the device and a distal portion14 configured to apply heat to sutures to fuse them together. The handleportion 12 can comprise a generally cylindrical body 16 and an actuator18. The body 16 can house additional components, such as electronicsand/or a power supply (e.g., one or more batteries). The actuator 18 cancomprise an electrical switch, a knob, a dial, a button, or othercontrol mechanism. The handle portion 12 can be coupled to a remotepower source in some embodiments.

As shown in FIG. 2, the distal portion 14 can comprise an extensionportion 20 of the body 16 that has a reduced width than the body, anelectrical heating element 24 extending distally from the extensionportion 20, and a sheath 22 that extends from the extension portion 20and surrounds the heating element 24. The sheath 22 can be generallycylindrical and can have a distal opening 26 positioned a small distancedistally from a distal end of the heating element 24. The sheath 22 canalso have a lateral opening 28 in a sidewall of the sheath adjacent tothe distal end of the heating element 24.

The heating element 24 can comprise a loop of wire or filament thatheats when an electrical current passes through it. The distal end ofthe heating element 24 can comprise various shapes, such as an eyeletshape through which sutures can pass, or a crescent shape configured tocurve around sutures.

In some embodiments, the heating element 24 can be axially,rotationally, and/or radially moveable relative to the sheath 22. Forexample, in some embodiments, the heating element can be retractedproximally within the sheath 22 while sutures are guided into or throughthe sheath, and then advanced distally relative to the sheath 22 inorder to cause the heating element to contact the sutures. In someembodiments, the heating element 24 can be moved radially within thesheath to contact the sutures. In some embodiments, the heating elementcan comprise two or more loops and the sutures can be positioned betweenthe loops. In other embodiments, the heating element 24 can be fixedaxially relative to the sheath 22.

In use, two or more suture portions 30A and 30B can be threaded throughthe distal opening 26 and out through the lateral opening 28 such thatthe suture portions pass adjacent to the heating element 24, as shown inFIG. 3. Typically, the two suture portions 30A, 30B are projecting froma surgical location in the body, and so the device 10 is moved inconjunction with the suture portions to guide the suture portionsthrough the openings 26 and 28 in the sheath 22. In some cases, twosuture ends can be introduced into the sheath 22 through the distalopening 26 without extending out through the lateral opening 28, suchthat the ends of the sutures can be fused together.

The distal portion 14 can be advanced along or over the suture portionsuntil a desired fusing location along the suture portions is adjacent tothe heating element 24. In some cases, this can include advancing thedistal portion 14 until the distal end of the sheath 22 contacts thetissue or other object from which the suture portions are protruding. Insome methods, the free ends of the suture portions 30A, 30B that extendout from the lateral opening 28 in the sheath can be grasped and pulledto a desired tension, using the distal end of the sheath 22 to hold thesurrounding tissue or material steady as the sutures are pulled taught.

When the distal portion is at the desired location along the sutureportions 30A, 30B such that the sections to be fused are adjacent theheating element 24 and/or the desired tension applied to the sutureportions, the user can actuate the actuator 18, which can cause theheating element 24 to advance distally within the sheath 22 and intocontact with the sutures and/or can cause an electrical current to flowthrough the heating element 24 and increase the temperature of theheating element. In some embodiments, two or more different actuatorsare included to separately control movement of the heating element andheating of the heating element. When the heating element is heatedsufficiently, the sections of the suture portions 30A, 30B that areadjacent to or in direct contact with the heating element are heated andfused together. The fusing of the suture portions can include meltingand/or cauterization of the suture material such that the material oftwo suture portions meld together to form a connection 32, as shown inFIG. 4. In some embodiments, the fusing of the suture portions causesthe end portions of the sutures beyond the connection 32 to be severedoff, leaving the connection 32 at the ends of the sutures, as shown inFIG. 4. In other embodiments, the end portions of the sutures beyond theconnection 32 can be manually cut off. The tissue is protected from theheating element 24 because the distal end of the sheath 22 remainspositioned distal to the distal end of the heating element when theheating element is actuated. The sheath 22 also protects the tissuelaterally from contacting the heating element.

After the sutures are fused, the device 10 can be removed and optionallyused to fuse addition suture portions by repeating the methods describedherein. In some embodiments, the device 10 can be reused for more thanone surgery, while other embodiments can be disposable after a singlesurgery. In some embodiments, the distal sheath 22 and/or the heatingelement 24, or the entire distal portion 14 can be removed, disposed,and replaced between surgeries.

In some embodiments, a heat-based suture fusing device, like thosedescribed herein, can be included as part of a suture clip deploymentdevice, such as the suture clip deployment devices disclosed in U.S.patent application Ser. No. 13/715,640, filed Dec. 14, 2012, andpublished as US 2013-0165953 A1, which is herein incorporated byreference. As shown in FIG. 5, in some embodiments, two suture portions30A, 30B can be secured together with an exemplary suture clip 34 andalso fused together at a connection 32. This can help further secure thesutures together and help prevent the sutures from pulling through thetissue. Any suitable suture clip can be used in such embodiments, suchas any of the exemplary suture clips disclosed in U.S. patentapplication Ser. No. 13/715,640.

FIGS. 6, 7, 8 and 8A show an exemplary suture clip delivery device 40that is configured to deploy an exemplary suture clip 50 onto anexemplary suture 59 (the suture 59 shown is not to scale forillustrative purposes, and can be significantly thicker in relation tothe clip 50). The device 40 comprises a handle 42 and an elongated shaft44. The shaft 44 can be long, narrow, and tubular, and can have an innerlumen 45 (FIG. 8A) with a distal opening 46. The clip 50 can be made ofan injection molded plastic, machined plastic, other polymericmaterials, metal based materials, or other suitable materials. The clip50 can comprise a support portion 52 having a cross-sectional shapecorresponding to the shape of the lumen 45 of the shaft 44, a flangedportion 54 having a broader diameter, and inner passageway 53 (FIG. 8A)extending through the support portion 52 and the flanged portion 54. Thebroad flange portion 54 can provide increased surface area for contactwith tissue to reduce the risk of pull-through or tissue damage. Thesupport portion 52 of the clip can be inserted into the distal opening46 to load the clip 50 into the device 40. In some embodiments, thesupport portion 52 and the lumen 45 of the shaft 44 can have a circularcross-sectional profile, as shown in FIG. 8A. In other embodiments, thesupport portion 52 and the lumen 45 of the shaft can have a non-circularcross-section profile to ensure proper rotational orientation of theclip 50 relative to the shaft. When loaded, the flange portion 54 canabut the distal end of the shaft 44, as shown in FIGS. 7 and 8, whichshow two cross-sectional views of the distal end of the shaft 44 withthe clip 50 loaded, taken along a longitudinal axis of the shaft 44 at90 degrees apart from each other.

With the clip 50 loaded in the device 40 and a suture 59 inserted intoor through the clip, the device can be used to secure the clip to thesuture. The device 40 can be configured such that manual actuation of alever 48, or other mechanism, causes a volume of liquid polymer to beinjected through the shaft 44 and into the passageway 53 (FIG. 8A)within the support portion 52 of the clip 50. UV radiation or othercuring means can then be used to solidify the polymer inside the clip 50and thereby secure the clip to the suture via the solid polymer. Asshown in FIGS. 7 and 8, the device 40 can further comprise one or morepolymer delivery tubes 56 that are coupled at a proximal end to a liquidpolymer source, such as in the handle 42 or external to the device 40,and coupled at a distal end to one or more polymer delivery tips 58,which extend radially through the sidewall of the support portion 52 ofthe clip 50 and into the passageway 53 between the inserted suture 59and the inner surface of the support portion 52.

The polymeric injection material can comprise, for example, a copolymerresin with a curing agent, a thermopolymer which is heated up and thencools once injected, or other known materials. In some embodiments, oncethe liquid polymer is injected into the clip, a UV curing device (eitherpart of the device 40 or separate), such as a UV radiation source, canbe applied to solidify the polymer. For example, some embodiments of thedevice 40 comprise a UV radiation source positioned in the handleportion and/or UV radiation emitter positioned near the distal end ofthe shaft 44. The suture 59 and/or the clip 50 can partially orcompletely bond with the injected polymer, providing a permanent bondbetween the suture and the clip.

The cross-sectional size of the shaft 44 and lumen 45 can be any sizeand can be used with any size of clip 50 and any size of innerpassageway 53, which can be used with any size or type of suture 59. Thedevice 40 and clip 50 can also be used to secure more than one suturetogether in the same manner. In some embodiments, the inner diameter ofthe passageway 53 through the clip 50 can be sized significantly largerthan the diameter of the suture 59, thereby making it easier to insertthe suture through the clip and providing space for the polymericmaterial to be injected.

The support portion 52 of the clip can comprise lateral openingscorresponding to the location of the polymer delivery tips 58. In someembodiments, the tips 58 can be rigid to aid in retaining the clip 50within the shaft 44, and in other embodiment, the tips 58 can be softand flexible. In some embodiments, the tips 58 can have a curved orsloped distal surface to facilitate inserting the clip support portion52 over the tips until the tips engage into holes in the sidewall of thesupport portion, as shown in FIG. 8. The tips 58 can be integrated withthe shaft 44 and delivery tubes 56 in some embodiments, and in otherembodiments the tips 58 can be integrated with the clip 50 itself. Insome embodiment, there is only one polymer delivery tube 56 and/or onlyone tip 58 for injecting polymeric material into the clip 50, while inother embodiments, there can be more than two delivery tubes 56 and/ormore than two tips 58.

In some embodiments, the inner surfaces of the clip 50 can comprisegeometric characteristics that prevent the polymeric material fromescaping from the clip once solidified.

After the clip 50 is deployed and secured to a suture, the device 40 canbe used to cut off the free end of the suture. In some embodiments, thedistal end of the shaft 44 can comprise a cutting means, such as a sharpedge, blade, heating element, etc., for cutting the suture.

To aid in releasing the clip 50 from the shaft 44, the device 40 cancomprise a release mechanism that causes the clip 50 to separate fromthe shaft 44, from the delivery tubes 56, and/or from the tips 58. Insome embodiments, the clip 50 is held within the shaft 44 via frictionfit between the support portion 52 and the inner surface of the shaft44. In some cases, this friction can be overcome by pulling the deviceproximally and relying on suture tension to pull the clip in theopposite direction. In some embodiments, a pushing device (not shown)can be positioned within the shaft 44 and proximal to the clip 50, andconfigured to move distally relative to the shaft 44 in order to pushthe clip 50 out of the shaft 44 after it is secured to the suture. Insome embodiments, the device 40 can be configured to move the tips 58radially out of the lateral holes in the clip support portion 52 inorder to disengage the clip 50 from the device 40.

FIGS. 9, 10, 11, and 11A show another exemplary suture clip deliverydevice 60 that is configured to deploy an exemplary suture clip 70 ontoan exemplary suture 79 (the suture 79 shown is not to scale forillustrative purposes, and can be significantly thicker in relation tothe clip 70). The device 60 comprises a handle 62 and an elongated shaft64. The shaft 64 can be long, narrow, and tubular, and can have an innerlumen 67 with a distal opening 66. A distal end portion of the shaft 64can comprise a heating element 65, such as an electrical heating elementor other means for providing heat.

The clip 70 can comprises a support portion 72 having a cross-sectionalshape corresponding to the shape of the lumen 67 of the shaft 64, aflanged portion 74 having a broader diameter, and inner passageway 73(FIG. 11A) extending through the support portion and the flanged portionfor receiving the suture 79. The broad flange portion 74 can provideincreased surface area for contact with tissue to reduce the risk ofpull-through or tissue damage. The support portion 72 of the clip can beinserted into the distal opening 66 to load the clip 70 into the device60. In some embodiments, the support portion 72 and the lumen 67 of theshaft 64 can have a circular cross-section profile. In otherembodiments, the support portion 72 and the lumen 67 of the shaft 64 canhave a non-circular cross-section profile to ensure proper rotationalorientation of the clip relative to the shaft. When loaded, the flangeportion 74 can abut the distal end of the shaft 64, as shown in FIGS. 10and 11, which show two cross-sectional views of the distal end of theshaft 64 with the clip 70 loaded, taken along a longitudinal axis of theshaft 64 at 90 degrees apart from each other.

With the clip 70 loaded in the device 60 and a suture 79 inserted intoor through the clip, the device can be used to secure the clip to thesuture. The device 60 can be configured such that actuation of a lever68, or other mechanism, causes the heating element 65 to heat thesupport portion 72 of the clip. For example, the heating element 65 canbe electrically coupled to a battery in the handle 62 and/or to anexternal power source. Heat from the heating element 65 can cause thesupport portion 72 to become secured to the suture 79. In someembodiments, the heat can cause the support portion 72 to shrink orconstrict radially around the suture 79 to mechanically and/orfrictionally secure the clip to the suture. In some embodiments, theheat can cause the support portion 72 and/or the suture 79 to partiallymelt and bond or adhere together. In some embodiments, the heat cancause the support portion 72 to chemically bond to the suture 79. Thesupport portion 72 of the clip, or the whole clip 70, can comprise apolymeric material, such as thermoset or thermoplastic polymer. In someembodiments, the clip can comprise a single layer polymer, and in someembodiments the clip can comprise a multi-layered polymer. In someembodiments, the clip can comprise a braided material. In someembodiments, the heat can activate an adhesive material coating theinner surface of the support portion 72 such that the adhesive adheresthe clip to the suture 79. The suture 79 and the clip 70 can partiallyor completely bond with each other, providing a permanent, strong bondbetween the suture and the clip.

In some embodiments, the clip 70 can comprise contoured and/or texturedinner surfaces that engages with the suture 79, which can increasecontact surface area, increase friction, and can present a tortuous pathfor suture once the clip has constricted around the suture. This canfurther enhance the attachment force between the clip and suture andincrease retention.

The cross-sectional size of the shaft 64 and lumen 67 can be any sizeand can be used with any size of clip 70 having any size of innerpassageway 73, which can be used with any size or type of suture 79. Thedevice 60 and clip 70 can also be used to secure more than one suturetogether in the same manner. In some embodiments, the inner diameter ofthe passageway 73 through the clip 70 can be sized significantly largerthat the diameter of the suture 79, thereby making it easier to insertthe suture through the clip.

After the clip 70 is deployed and secured to a suture, the device 60 canbe used to cut off the free end of the suture. In some embodiments, thedistal end of the shaft 64 can comprise a cutting means, such as a sharpedge, blade, heating element, etc., for cutting the suture.

To aid in releasing the clip 70 from the shaft 64, the device 60 cancomprise a release mechanism that causes the clip 70 to separate fromthe shaft 64. In some embodiments, the clip 70 is held within the shaft64 via a friction fit between the support portion 72 and the innersurface of the shaft. In some embodiments, this friction is reduced oreliminated when the support portion 72 is heated and becomes secured tothe suture 79, such as because the support portion shrinks in diameter.In some embodiments, the friction can be overcome by pulling the device60 proximally and relying on suture tension to pull the clip 70 in theopposite direction. In some embodiments, a pushing device (not shown)can be positioned within the shaft 64 and proximal to the clip 70, andconfigured to move distally relative to the shaft 64 in order to pushthe clip 70 out of the shaft after it is secured to the suture.

FIGS. 12-26 show an exemplary embodiment of another suture securementdevice 102. The device 102 can be used to fuse sutures together and/orcut off free ends of sutures using heat. Sutures can be inserted into adistal end of the device 102 and manually tensioned, then the device canbe actuated to apply heat to the sutures to melt them, which can severoff free ends of the sutures and can fuse the sutures together. Thedevice 102 can be applied, for example, to two ends of a single suturethat is threaded through a patient's body with the free ends exposed.The two exposed ends of the suture can be inserted into the device 102,tensioned as desired, and then fused together to secure the suture inthe body at the desired tension, and the free ends beyond the fused areacan be severed and removed, providing an effective suture securementwithout the use of knots or clips or other retaining devices.

The illustrated embodiment of the device 102 comprises a handle portion104 and an elongated shaft portion 106 extending from the handleportion. The handle portion 104 can include an outer housing 108 and atrigger 110 for actuating the device. The trigger 110 can comprise alever that pivots relative to the housing 108, such as about pivot 120as illustrated in FIG. 14, or can comprise other mechanical orelectronic mechanisms for actuating the device, including automatedand/or motorized mechanisms.

As shown in FIG. 14, the handle portion 104 can further compriseselectronics 118, such as a battery or other power source, within thehousing 108 for providing electrical power to a heating element 124 inthe shaft portion 106. In other embodiments, the device 102 can beelectrically coupled to an external power source for providingelectrical power to the heating element 124, such as via a cord thatplugs into an outlet.

The shaft portion 106 includes an outer shaft 112 that is fixed to orcoupled to the housing 108 and extends distally from the handle portion104 such that the shaft portion 106 can be inserted into a body cavityto access sutures. An inner shaft 114 is positioned within the outershaft 112 and is slidably movable proximally and distally within a lumenof the outer shaft 112. A proximal end portion of the inner shaft 114can be coupled to the trigger 110, such as at pivot 122, in the handleportion 104 such that actuation of the trigger causes the inner shaft tomove distally within the outer shaft 112. Releasing the trigger 110 cancause the inner shaft to move back proximally within the outer shaft,such as via a spring or other biasing mechanism (not shown) attached tothe inner shaft or the trigger and to the housing 108. In otherembodiments, after the trigger 110 is actuated from a starting positionto an actuated position, the trigger is manually moved back to thestarting position to cause the inner shaft 114 to move back proximally.

Referring to FIG. 15, the heating element 124 can be positioned withinthe inner shaft 114 and can move in unison with the inner shaft 114within the outer shaft 112 in response to actuation of the trigger 110.In FIG. 15, the outer shaft 112 is partially cut away in order to betterillustrate other components within the outer shaft. The outer shaft 112typically extends the entire length of the shaft portion with a distalend positioned around the suture collar 126. The heating element 124 ispositioned within the inner shaft 114 and the distal end distal end ofthe heating element 124 is spaced radially from the inner surfaces 142of the distal end portion of the inner shaft 114. The heating element124 can further comprise a proximal portion 125 (FIG. 18) having alarger diameter and mounted further proximally within the inner shaft.The heating element 124 can be coupled to the electronics 118 in thehandle portion 104 and/or to an external power source and/or controllervia wires 116 running through the shaft portion 106, such as within theinner shaft 114, as illustrated in FIG. 14.

The device 102 has an open configuration, shown in FIGS. 15-18, and aclosed configuration, shown in FIGS. 19-22. Actuating the trigger 110can cause the device 102 to move from the open configuration to theclosed configuration, and releasing the trigger 110 or returning thetrigger to its pre-actuation position can move the device 102 from theclosed configuration to the open configuration.

In the open configuration (FIGS. 15-18), the device 102 can receivesutures 130 at a distal end of the shaft portion 106 and the receivedsutures can optionally be tensioned by pulling on free ends 132 of thesutures that protrude out of the side of the shaft portion 106. In theclosed position (FIGS. 19-22), the received sutures 130 can be grippedby a suture holder 128 to maintain tension in the sutures and/or manualtension can be maintained, and the heating element is applied to thesutures 130 fuse them together and/or cut off the free ends 132 of thesutures.

The outer shaft 112 can be tubular, such as generally cylindrical, or itcan have a non-circular cross-section. The shaft 112 defines an innerlumen in which the inner shaft 114 slides. The inner shaft 114 can havean outer surface 137 that generally conforms to the inner lumen of theouter shaft 112 and provides for minimal frictional contacttherebetween. As shown in FIG. 15, the distal end portion of the innershaft 114 can include a distal end 138, a beveled or sloped surface 140,an inner cavity 142 that surrounds the heating element 124, a lateralslot 144 that extends proximally from the distal end 138 in one side ofthe inner shaft, and/or one or more radial vents 146, 147 communicatingfrom the inner cavity 142 radially to the outer surface 137 proximatethe heating element 134.

The outer shaft 112 has a distal end 134, a lateral slot 136 thatextends proximally from the distal end 134 in one side of the outershaft, and/or one or more radial vents (not shown) communicating fromits inner lumen radially to its outer surface. The lateral slots 136 and144 can be aligned circumferentially to provide a lateral openingextending radially through both the inner and outer shafts. Vents in theouter shaft 112 can further be aligned, both circumferentially andlongitudinally, with the vents 146, 147 in the inner shaft 114 when theinner shaft is in the distal, closed position in order to vent heat fromthe heating element radially out of the device and/or to allowcross-flow of air through the shaft portion 106 past the heatingelement.

In some embodiments, the device 102 can further comprise a suture collar126 at the distal end 134 of the outer shaft 112. The collar 126 can begenerally disk shaped having generally flat distal and proximal surfacesand a round perimeter 176 that mounts within the distal end of the innerlumen of the outer shaft. The collar 126 includes a central opening 170that can receive and collar sutures extending proximally through thecollar 126 into the inner lumen of the outer shaft. The collar 126 canfurther comprise a lateral gate 172 to allow intermediate portions ofsutures to be inserted laterally into the central opening 170 butrestricts or prevents sutures from escaping laterally out of the centralopening.

As shown in FIG. 26, the collar 126 includes a radial slot or mouth 174that extends from the lateral gate radially to the outer perimeter 176.The radial slot 174 can be generally tapered or wedge shaped, such thatits width decreases moving radially inwardly. This can assist indirecting an intermediate portion of a suture radially toward thelateral gate 172 and into the central opening 170. The radial slot 174can be circumferentially aligned with the lateral slots 136, 144 in theouter and inner shafts 112, 114, to allow sutures to be insertedlaterally into the collar 126 and into the suture holder 128 with freeends of the sutures extending laterally out through the lateral slots inthe shafts.

As shown in FIG. 26, the lateral gate 172 can comprise a tang or flapthat extends generally circumferentially along the side of the centralopening 170, blocking communication between the radial slot 174 and thecentral opening 170. The lateral gate 172 can be elastically deformablesuch that radially inward force from a suture being moved radiallyinwardly through the radial slot 174 causes the lateral gate 172 toresiliently deflect into the central opening 170, opening a passagewaybetween radial slot and the central opening large enough for the sutureto pass through into the central opening. The lateral gate 172 canextend past the radial slot 174 and overlap the radial surfacesurrounding the central opening such that the lateral gate is blockedfrom deflecting radially outwardly, which can prevent collared suturesfrom moving radially outwardly from the central opening 170 through theradial slot 174 and escaping from the collar 126.

In embodiments of the device 102 comprising a suture holder 128, thesuture holder 128 can be positioned within the distal end portion of theouter shaft, such as mounted to a proximal surface of the suture collar126 and/or mounted to an inner surface of the outer shaft 112. Thesuture holder 128 has an open position (FIGS. 15-18) and a closedposition (FIGS. 19-25). In the open position, the suture holder 128 isconfigured to receive sutures axially and/or radially entering thesuture holder, and in the closed position the suture holder isconfigured to grip and hold received sutures and prevent longitudinaland radial movement of held sutures relative to the outer shaft 112. Thesuture holder 128 is shown isolated in the closed position in FIGS.23-25.

The suture holder 128 can comprise a first portion 152 and a secondportion 150 that are hingedly coupled together for articulation betweenthe open position and the closed position, such as in a clamshell-typeconfiguration. The first portion 152 of the suture holder can be fixedto the suture collar and/or to the outer shaft, while the second portion150 is free to move between the open and closed positions.

The suture holder 128 can comprise a sloped or tapered proximal outersurface 154 extending circumferentially around, or partially around,both the first and second portions of the suture holder. In otherembodiments, the sloped surface 154 may be present only on the movablesecond portion 152. As the inner shaft 114 moves distally duringactuation of the device 102, the sloped surface 140 at the distal end ofthe inner shaft (see FIG. 15) can contact the sloped surface 154 at theproximal end of the suture holder, and the engagement of these slopedsurfaces causes the movable second portion 150 of the suture holder tomove toward the first portion 152 and close the suture holder to theclosed position. In the closed position, as shown in FIGS. 19 and 20,the inner surface 142 of the inner shaft 114 overlies outer surfaces ofthe suture holder 128 and retains it in the closed position. In FIG. 19,the outer shaft 112 is partially cut away in order to better illustrateother components within the outer shaft.

As best shown in FIGS. 23-25, the suture holder 128 can include abiasing mechanism 158, such a resiliently flexible connector or springmember, that couples the first and second portions of the suture holdertogether, allows for controlled motion between the open and closedpositions, and biases the suture holder toward the open position. Due tothe opening bias, when the inner shaft 114 is retracted proximally andit moves out of restraining contact with the outer surfaces of thesuture holder, the suture holder can resiliently move back to the openposition, releasing the fused together sutures held in the sutureholder.

As best shown in FIG. 17, the suture holder 128 can include one or moregrooves or recesses (e.g. 160, 162) and/or one or more ridges orprojections (e.g., 164, 166) on opposing surfaces of the first andsecond portions 150, 152 of the suture holder to enhance its ability tosecurely grip received sutures and keep them from moving longitudinallyrelative to the suture holder in the closed position. For example, theridge 164 can cooperate with the groove 160 to pinch or kink heldsutures, and the ridge 166 can cooperate with the groove 162 to pinch orkink held sutures. In some embodiments, other forms of tractionenhancement can be provided, such as surface texturing or teeth, to helpgrip the sutures.

The suture holder 128 can further comprises a proximal recess or cup 156formed between the first and second portions 150, 152 of the sutureholder when in the closed position (FIG. 22). The distal floor of thiscup 156 can be formed, for example, by walls of the ridge 166 and thegroove 168. The cup 156 can be generally cylindrical in shape, or cantaper is diameter moving distally, or can have other shapes. In theclosed position, held sutures 130 pass through the cup 156 proximallybefore bending radially outwardly and exiting through the lateral slots144, 136 in the inner and outer shafts.

The cup 156 of the suture holder 128 can receive a distal end of theheating element 124, which can have a diameter slightly smaller than theinner diameter of the cup, when the device 102 is actuated and theheating element moves distally within the outer shaft 112. As theheating element moves into proximity with the cup 156, the heatingelement can contact the held sutures 130 and begin to melt them. As theheating element 124 enters the cup 156, the free ends 132 of the suturecan be severed off. Within the cup 156, the remaining ends of the heldsutures 130 can be melted and fused together, forming a fused regionthat conforms generally to the shape of the cup and the distal end ofthe heating element 124. When the heating element is subsequentlyretracted proximally from the cup 156, the fused portion of the sutures130 can cool and harden, forming a secure connection between thesutures. Any number of sutures can be cut and/or fused at the same timein this manner, though typically two sutures are acted upon at a time.The fused portion of the sutures can be small enough such that, when thesuture holder 128 opens, the fused portion of the sutures can slidedistally out of the device 102 through the central opening 170 of thesuture collar 126. In some embodiments, surfaces of the suture holder128 can be coated with a non-stick material, such as PTFE, to helprelease the fused sutures.

An exemplary method of using the device 102 can comprise the following.One or more sutures can initially be placed in a subject, be it a humanpatient or animal. The placed suture or sutures can have free portionsextending from the subject that require securement at a desired tension.Instead of tying the free portions in knots or applying bulky clips tosecure the sutures, the device 102 can be used to fuse the suturestogether to secure them and/or cut off the remaining free portions.

Intermediate portions of the tensioned sutures (i.e., portions of thesutures spaced from ends of the sutures) can be laterally inserted intothe distal end portion of the shaft portion 106 of the device 102. To dothis, the distal end of the shaft portion 106 of the device can beplaced adjacent to the location where a suture exits the tissue or otherstructure of the subject. While the suture is manually held undertension, an intermediate portion of the suture can be forced to movelaterally into the radial slot 172 of the suture collar 128 and into thelateral slot 136 of the outer shaft 112. This can be done by urging theshaft portion 112 (in the open position) against the side of a tensedsuture, for example. As the suture moves radially inwardly through theradial slot 172, it can contact the lateral gate 172, causing it to openinwardly, and allowing the suture to move into the central opening 170of the suture collar 126. The suture also moves laterally into the opensuture holder between the first and second portions 150, 152.

Once the sutures have been collared within the central opening 170 ofthe suture collar 126, the tension on the sutures can be manuallyadjusted to a desired level by pulling the ends 132 of the suturesand/or by pressing the distal end of the shaft portion 106 against thetissue or structure from which the sutures project. Once the sutures arecollared and under the desired tension, the device 102 can be actuated.

Pulling the trigger 110, or otherwise causing actuation of the device102, causes the inner shaft 114 and heating element 124 to move distallyrelative to the outer shaft 112, suture collar 126, and suture holder128. Distal motion of the inner shaft 114 causes contact between theslope surface 140 of the inner shaft and the sloped surface 154 of thesuture holder 128, which closes the suture holder and grips the suturesat the desired tension. For example, actuation of the device 102 can bedone while the distal end of the shaft portion 106 is pressed againsttissue around the suture exit point to maintain the desired tension.Actuation of the device 102 also causes the heating element 124 to heatup and move into contact with the sutures proximal to the grippinglocation of the sutures. The heating element 124 can be fully heated toan operative temperature before it contacts the sutures, or can bepartially heated at contact with the sutures, in order to providedesired cutting and fusing properties. Once in contact with the sutures,the heating element 124 can be maintained in contact with the sutures atthe operative temperature for a period of time, such as up to 5 seconds,such as 2 to 3 seconds, to fully fuse and/or sever the sutures. Theheating element 124 then be retracted or allowed to remain in contactwith the sutures in the closed/actuated position for an additionalperiod of time, such as up to another 10 seconds, such as 4-5 seconds,to allow the heating element to cool down and allow the fused portion ofthe sutures to cool and harden while the distal end of the heatingelement remains inserted into the cup 156 to provide a mold wall thathelps shape and contain the cooling fused portion until it is fullysolid. The electronics 118 in the handle portion 104 can control thetime period before the current to the heating element is reduced orturned off to allow it to cool down. For example, the electronics 118can apply power to the heating element for a predetermined period oftime after the trigger 110 is fully actuated. In other embodiments,temperature sensors can be located at or near the heating element and/orthe suture holder and can sense the temperature of the heating elementand/or the fused portion of the sutures and can feed such temperaturedata back to the electronics such that the electronics can determinewhen to provide and/or cut the power to the heating element based on thesensed temperature date. In other embodiments, sensed temperature datacan be displayed at the handle or elsewhere to allow a user to decide,based on the displayed temperature data, when to release the trigger110, or otherwise de-actuate the device, and separate the heatingelement from the fused sutures. The vents 146, 147 in the inner shaft,vents in the outer shaft, and lateral slots 136, 134 in the shafts canprovide enhanced cooling of the heating element by allowing airflow andconvection cooling, such that the cooling time needed can be reduced,and desirably shortening the entire process.

When the device is de-actuated, the heating element 124 and inner shaftreturn distally within the outer shaft and the suture holder 128 canresiliently open, releasing the fused sutures to slide out of the devicethrough the central opening 170 of the collar 126.

The device 102 can be reusable any number of time to subsequently secureand/or cut additional sutures. After releasing one fused group ofsutures, the device can be immediately ready to be reused on othersutures. Further, in many embodiments, no clips or other devices ormaterials are consumed by the device or need to be loaded into thedevice prior to use. However, in other embodiments, the device 102 canbe configured to be used to deploy a suture clip or to sutures, such asdescribed with the embodiments of FIGS. 6-11.

In still other embodiments and methods, the device 102 can be used witha fusing sleeve to help fusing the sutures together. For example, FIG.27 shows the device 102 with an exemplary fusing sleeve 200 positionedaround the sutures 130 within the suture holder 128, such as in the cupportion 156 of the suture holder. The suture holder 128 may be slightlylarger in such embodiments to accommodate the fusing sleeve 200. Whenthe device 102 is actuated, the heating element 124 can melt and/orshrink the sleeve 200 to help secure the sutures together. In somecases, the sutures and the sleeve 200 can melt and fuse together to forma single fuse. In some cases, the sutures may comprise a material thatdoes not naturally fuse together well, and the sleeve 200 can provide orstrengthen the bond between the sutures. In some cases, the sleeve 200may shrink circumferentially instead of or in addition to melting,thereby constricting around the sutures to hold them together. Thesleeve 200 can comprise a polymeric material, such as a thermoplastic orthermoset. For example, the sleeve 200 can comprise LDPE, HDPE, PEBAX,PU, and/or other polymers. In other embodiments, the sleeve 200 cancomprise materials other than polymers that can melt, shrink, and/orfuse together to the sutures to strengthen the attachment between thesutures. The sleeve 200 can be positioned around the sutures prior toinserting the sutures into the suture holder. With the sleeve 200positioned around the sutures, the sleeve can be inserted laterallythrough the slot in the outer shaft and into the cup portion 156 of thesuture holder along with the sutures, and then the device can beactuated.

In some embodiments, the device 102 can further comprise an activecooling system to speed up the cooling process after the heating elementhas fused the sutures together. Such an active cooling system can beincluded as an alternative to, or in addition to, a passive coolingsystems, such as the radial vents 146, 147. In some embodiments, anactive cooling system can comprise an air conduit extending along theshaft portion, such as along the outer shaft, from the handle portion toadjacent the suture holder. The air conduit can be coupled to apressurized air source that blows air over the suture holder, theheating element, and/or the fused sutures to speed up the coolingprocess. For example, the air source can be an external air supplysource in an operating room or can be a pump in the handle portion ofthe device.

Some embodiments of devices disclosed herein can be used to fuse suturesextending from opposite directions through the device, rather thansutures that extend in the same direction as is shown in FIG. 4. Forexample, one or more sutures can extend from a first exit point in thetissue or a prosthetic device, into the device through a lateral slot inthe outer shaft, through the suture holder, through the suture collar,and have its free end or ends extending out from the suture collar. Oneor more other sutures can extend from a second exit point in the tissueor the prosthetic device, into the device through the suture collar,through the suture holder, and have free end or ends extending outthrough the lateral slot in the outer shaft, such that the sutures laygenerally parallel through the device but extend in opposite directionsfrom the different exit points. In such an arrangement, the oppositelyextending sutures can be fused together with the device with their freeends projecting in opposite directions. This can result in the fusedsutures being able to lay flat against a surface of the tissue or asurface of the prosthetic device between the exit points of the opposingsutures. This can also reduce the risk of the fused connection failingwhen tension is applied to the fuse due the two sutures being pulled inopposite directions.

Any suitable materials can be used in the construction of the device102. For example, the housing, trigger, inner and outer shafts, heatingelement, suture holder, and/or suture collar can all comprise stainlesssteel and/or other suitable materials. The components of the device 102are desirable sufficiently rigid to be structurally supportive, havesufficient resilient deformability, such as in the case of the lateralgate of the suture collar and suture holder biasing member, havesufficient resistance to heat released by the heating element, do notbond with the suture material, are non-toxic and otherwise notphysiologically harmful, can be sterilized, and/or have other desirableproperties.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, devices, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, devices, and systems are not limited to anyspecific aspect or feature or combination thereof, nor do the disclosedembodiments require that any one or more specific advantages be presentor problems be solved.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language. Forexample, operations described sequentially may in some cases berearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods.

As used herein, the term “and/or” used in a list of elements means anyone or more of the listed elements. For example, the phrase “A, B,and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “B and C” or “A, Band C.”

As used herein, the term “coupled” generally means physically orelectrically linked and does not exclude the presence of intermediateelements between the coupled items absent specific contrary language.

In view of the many possible embodiments to which the principlesdisclosed herein may be applied, it should be recognized that theillustrated embodiments are only preferred examples and should not betaken as limiting the scope of the disclosure. Rather, the scope of thedisclosure is at least as broad as the following claims. We thereforeclaim all that comes within the scope of these claims.

We claim:
 1. A suture securement device, comprising: a handle; anelongated outer shaft having a proximal end portion coupled to thehandle and a distal end portion opposite the proximal end; an innershaft movable proximally and distally within the outer shaft; a sutureholder at the distal end portion of the outer shaft, the suture holderhaving an open position and a closed position, wherein in the openposition the suture holder is configured to receive sutures, and in theclosed position the suture holder is configured to hold sutures andprevent longitudinal movement of held sutures relative to the outershaft; and an electrical heating element positioned within the outershaft; wherein actuation of the device causes the inner shaft and theheating element to move distally relative to the outer shaft and thesuture holder, such that the distal end portion of the inner shaftcauses the suture holder to move from the open position to the closedposition, and such that the heating element moves into the proximity ofthe suture holder to fuse together sutures held by the suture holder;wherein the suture holder is adapted to separate from the fused suturesafter the sutures are fused together and the suture holder is adapted toremain part of the suture securement device as the suture securementdevice is withdrawn from the fused sutures.
 2. The device of claim 1,wherein the suture holder comprises a first portion and a second portionthat are hingedly coupled together for articulation between the openposition and the closed position.
 3. The device of claim 2, wherein thefirst and second portions of the suture holder are coupled by anelastically flexible hinge that biases the first and second portionstoward the open position, such that the suture holder releases the fusedsutures when the inner shaft moves proximally off of the suture holder.4. The device of claim 2, wherein the first and second portions of thesuture holder are both configured to move relative to the outer shaftwhen the suture holder articulates between the open and closedpositions.
 5. The device of claim 1, wherein a first portion of thesuture holder is fixed relative to the outer shaft and a second portionof the suture holder moves between the open position and the closedposition.
 6. The device of claim 5, wherein the first portion of thesuture holder is fixed to a proximal side of a suture collar at thedistal end of the outer shaft.
 7. The device of claim 6, wherein thesuture collar comprises a central opening for collaring sutures receivedby the suture holder, and a lateral gate that allows sutures to enterlaterally into the central opening in a radially inward directionthrough the lateral gate, and the lateral gate blocks sutures fromexiting the central opening in a radially outward direction.
 8. Thedevice of claim 7, wherein the outer shaft comprises a slot extendingproximally from a distal end of the outer shaft, the slot beingcircumferentially aligned with the lateral gate in the suture collar anda lateral opening in the suture holder such that an intermediate portionof a suture can be laterally inserted through the slot and through thelateral gate and into the central opening and into the suture holder. 9.The device of claim 1, wherein the suture holder has a sloped proximalsurface and the inner shaft has a sloped distal surface, and contactbetween the sloped proximal surface and the sloped distal surface upondistal movement of the inner shaft causes the suture holder to close.10. The device of claim 1, wherein the suture holder comprises aproximal recess and the heating element is moveable at least partiallyinto the proximal recess.
 11. The device of claim 1, wherein the heatingelement is configured to cut off free ends of the sutures held by thesuture holder as the heating elements moves into the proximity of thesuture holder.
 12. The device of claim 1, wherein the inner shaftcomprises a longitudinal slot at the distal end portion of the innershaft and, in the closed position, free ends of sutures held by thesuture holder extend out of the device through the longitudinal slot.13. The device of claim 1, wherein the outer shaft comprises alongitudinal slot at the distal end portion of the outer shaft and, inthe open position, free ends of sutures received by the suture holderextend out of the device through the longitudinal slot to allow manualtensioning of the sutures.
 14. The device of claim 1, wherein theheating element is positioned within the inner shaft and the inner shaftcomprises at least two radial openings adjacent to the heating elementto vent heat from the heating element.
 15. The device of claim 1,wherein the suture holder is configured to receive the sutures with aheat-activated sleeve positioned around the sutures, such that thesleeve is received within the suture holder and the sleeve fuses to thesutures in response to heat from the heating element.
 16. The device ofclaim 1, further comprising an air conduit extending from the handle tothe distal end portion of the outer shaft and configured to conduct airto the distal end portion of the outer shaft to help cool the heatingelement or fused sutures.
 17. The device of claim 1, wherein the deviceis configured to receive sutures to be fused such that the suturesextend axially through a distal opening in the device and axiallythrough the suture holder.
 18. A suture securement device, comprising: ahandle; an elongated outer shaft having a proximal end portion coupledto the handle and a distal end portion opposite the proximal end; asuture collar at the distal end portion of the outer shaft, the suturecollar having a central opening for collaring sutures and a lateral gatethat allows an intermediate portion of a suture to enter laterally intothe central opening in a radially inward direction through the lateralgate, and the gate blocks sutures from exiting the central opening in aradially outward direction; and an electrical heating element positionedwithin the outer shaft; wherein actuation of the device causes theheating element to fuse together sutures collared by the suture collar;wherein the outer shaft comprises a slot extending proximally from adistal end of the outer shaft, the slot being circumferentially alignedwith the lateral gate in the suture collar such that intermediateportions of a sutures can be laterally inserted through the slot in theouter shaft and through the lateral gate and into the central opening tocollar the sutures.
 19. The device of claim 18, wherein the suturecollar is generally disk-shaped and further comprises a generallywedge-shaped slot extending radially from a radially outer perimeter ofthe suture collar to the lateral gate.
 20. The device of claim 18,wherein the lateral gate comprises an elastically flexible flap thatdeflects to allow sutures to pass into the central opening.
 21. Thedevice of claim 20, wherein radially inward force from a suture causesthe flap to elastically deflect into the central opening to open thelateral gate.
 22. A suture securement device, comprising: a handleportion comprising a trigger and an electrical power source; and anelongated shaft portion extending from the handle portion, the shaftportion comprising: a tubular outer shaft having a proximal end attachedto the handle portion, a distal end opposite the proximal end, an innerlumen, and an outer slot extending proximally from the distal end of theouter shaft; an inner shaft having a proximal end coupled to thetrigger, a distal end opposite the proximal end, an inner slot extendingproximally from the distal end of the inner shaft, the inner shaft beingmovable longitudinally within the inner lumen of the outer shaft viaactuation of the trigger; a suture collar at the distal end of the outershaft, the suture collar having a central opening for collaring suturesand a lateral gate that allows sutures to laterally enter into thecentral opening in a radially inward direction via the outer slot in theouter shaft, and the gate blocks sutures from exiting the centralopening in a radially outward direction; a suture holder comprising afirst portion and a second portion that are hingedly coupled together,the first portion being attached to a proximal side of the suture collarand the second portion being free to articulate between an open positionand a closed position, wherein in the open position the suture holder isconfigured to receive sutures between the first and second portions thatextend through the central opening of the suture collar, and in theclosed position the first and second portions of the suture holder closetogether to grip the sutures and prevent longitudinal movement of thesutures relative to the shaft portion; and a heating element positionedwithin the inner shaft near the distal end of the inner shaft, theheating element being electrically coupled to the electrical powersource; wherein actuation of the trigger causes the inner shaft and theheating element to move distally relative to the outer shaft, the suturecollar, and the suture holder, such that the distal end of the innershaft moves over the suture holder and causes the second portion of thesuture holder to articulate to the closed position, and such that adistal end of the heating element moves into a proximal recess in thesuture holder, cuts off free ends of the held sutures, and fusestogether remaining ends of the sutures within the suture holder.